NDC 0065-8063

GenTeal Tears Moderate Preservative Free

Dextran 70, Hypromellose 2910

GenTeal Tears Moderate Preservative Free is a Ophthalmic Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is Dextran 70; Hypromellose 2910 (4000 Mpa.s).

Product ID0065-8063_0bdcea3f-656b-44b8-82e6-f17af8f79659
NDC0065-8063
Product TypeHuman Otc Drug
Proprietary NameGenTeal Tears Moderate Preservative Free
Generic NameDextran 70, Hypromellose 2910
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2017-12-22
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart349
Labeler NameAlcon Laboratories, Inc.
Substance NameDEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S)
Active Ingredient Strength1 mg/mL; mg/mL
Pharm ClassesIncreased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0065-8063-01

36 VIAL, SINGLE-DOSE in 1 CARTON (0065-8063-01) > .9 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2017-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0065-8063-01 [00065806301]

GenTeal Tears Moderate Preservative Free SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-12-22

Drug Details

Active Ingredients

IngredientStrength
HYPROMELLOSE 2910 (4000 MPA.S)3 mg/mL

OpenFDA Data

SPL SET ID:37686e54-e64d-47c8-b082-b944a23cf6f1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1739858
  • 309714
  • NDC Crossover Matching brand name "GenTeal Tears Moderate Preservative Free" or generic name "Dextran 70, Hypromellose 2910"

    NDCBrand NameGeneric Name
    0065-8063GenTeal Tears Moderate Preservative Freedextran 70, hypromellose 2910
    0065-0416Tears Naturale Freedextran 70, hypromellose 2910
    0065-5060Tears Naturale Freedextran 70, hypromellose 2910
    0065-5040Tears Naturale II PolyquadDextran 70, Hypromellose 2910
    0363-1678Walgreens Artificial Tears Lubricant Eye DropsDextran 70, Hypromellose 2910
    0363-1701Walgreens Artificial Tears Lubricant Eye DropsDextran 70, Hypromellose 2910

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